Composition and method for orally administering one or more active agents to a pet

ABSTRACT

A composition and method for administering an active agent to a pet, such as a dog, a cat or a horse. The composition may comprise a yogurt-based chewable delivery matrix and a plurality of water-soluble film pieces dispersed throughout the chewable delivery matrix. The composition may also comprise a delivery matrix having at least 15% by weight of crude protein and a plurality of water-soluble film pieces dispersed throughout the delivery matrix. The plurality of water-soluble film pieces encompass an active agent therein, wherein the active agent is rapidly released from the composition upon contact with saliva from the pet. At least a portion of the released active agents may be oromucosally absorbed by the pet.

PRIORITY CLAIM

This application claims priority to U.S. Provisional Application Ser.No. 62/088,313 filed on Dec. 5, 2014, and U.S. Provisional ApplicationSer. No. 62/148,454 filed Apr. 16, 2015, and to U.S. application Ser.No. 14/955,932 filed Dec. 1, 2015, the entire contents of each arehereby incorporated by reference herein.

FIELD OF INVENTION

The present invention relates generally to chewable pet treatscomprising one or more active agents. More particularly, the inventionrelation to the use of a chewable matrix, such as chewable treat, fordelivering active agents to an animal or pet.

BACKGROUND

It may be advantageous to the health of a pet, for example, a dog or acat, to administer a vitamin, a nutrition supplement, a pharmaceuticalingredient, or other active agents, to improve the health of the pet.Although these active agents can benefit the pet's health, it is often adifficult process to administer the active agents to the pets. Thesebeneficial active agents have typically been provided in the form of asolid pill (e.g., tablet or gelatin capsules) or a liquid (e.g., viscousgel) that requires the pet owner to forcibly administer the pill orliquid to the pet. For example, administration of the active agents mayrequire the pet owner to manually force open the pet's jaw, insert hishand into the pet's mouth, and force the pill or liquid down the pet'sthroat. This forcible oral administration of a composition is oftenuncomfortable and stressful for the pet and often resisted by the pet.Therefore, pet owners have had to find different ways to trick the petto comply with such forcible oral administration. Additionally, thestress, discomfort, and resistance by the pet are particularlyproblematic for regular administration of active agents to the pet(e.g., once daily, two daily), which requires regular and repeat stressto the pet.

Therefore, there is a continuing need in the art for orally administeredcompositions that can improve delivery of one or more active agents to apet. It is therefore an object of the present invention to provide pettreat compositions comprising one or more active agents which can beeasily administered to a pet.

SUMMARY OF THE INVENTION

In accordance with the foregoing objectives and others, one embodimentof the present invention provides a chewable composition formulated fororal delivery to a dog or a cat. The composition comprises a chewabledelivery matrix comprising a yogurt powder, a flavoring agent palatableto the dog or cat, and water. The yogurt powder being present in atleast 3% by weight of the chewable composition. The composition alsocomprises at least about 0.01% by weight of a plurality of water-solublefilm pieces dispersed homogeneously throughout the chewable deliverymatrix. The plurality of water-soluble film pieces comprise an activeagent and a coloring agent therein. The active agent is rapidlyreleasable from the chewable composition upon contact with saliva fromthe dog or cat. The water in the chewable delivery matrix is in anamount selected for mixing with the plurality of water-soluble filmpieces without causing aggregation of the water-soluble film pieces.

In another embodiment, a method for oral delivery of an active agent toa dog or a cat is provided. The method comprises orally administering achewable composition comprising a delivery matrix and a plurality ofwater-soluble film pieces dispersed homogenously throughout the matrix.The plurality of water-soluble film pieces include the active agenttherein. The method also includes rapidly dissolving a first portion ofthe plurality of water-soluble film pieces in a mouth of the dog or catupon contact with saliva from the dog for oromucosal delivery of theactive agent to the dog or cat. The method further includes subsequentlyreleasing the active agent from a second portion of the plurality ofwater-soluble film pieces for delivery to a gastrointestinal track ofthe dog or cat.

In a further embodiment, a composition formulated for oral delivery to adog or a cat is provided. The composition comprises a delivery matrixcomprising at least 15% by weight of crude protein, a flavoring agentpalatable to the dog or the cat, and water. The composition alsocomprises at least about 0.01% by weight of a plurality of water-solublefilm pieces dispersed homogeneously throughout the delivery matrix, theplurality of water-soluble film pieces comprise an active agent and acoloring agent therein, the active agent being rapidly releasable fromthe composition upon contact with saliva from the dog or the cat. Thewater in the delivery matrix is in an amount selected for mixing withthe plurality of water-soluble film pieces without causing aggregationof the water-soluble film pieces.

These and other aspects of the invention will become apparent to thoseskilled in the art after a reading of the following detailed descriptionof the invention, including the appended claims.

DETAILED DESCRIPTION

In the following description of the invention, it is to be understoodthat the terms used have their ordinary and accustomed meanings in theart, unless otherwise specified. The term “active agent” is intended tobroadly refer to any substance administered to an individual pet toachieve a biological effect. The term “active agent” includes, withoutlimitation, vitamins, minerals, nutritional supplements, herbalremedies, pharmaceutical agents, and the like. All weights referred toherein are given in terms of “% by weight” of the total composition,unless otherwise indicated.

An exemplary embodiment of the present invention includes a compositionformulated for oral delivery to a pet (e.g., a dog, cat or horse)comprising a delivery matrix and a plurality of water-soluble filmpieces dispersed therein. The water-soluble film pieces appearconfetti-like and dispersed throughout the delivery matrix.Specifically, the water-soluble film pieces may be dispersedhomogeneously, or substantially homogenously throughout the deliverymatrix. The pet-ingestible composition may include any suitable amountsof the water-soluble film pieces. In one embodiment, the pet-ingestiblecomposition may include at least about 0.01% by weight of water-solublefilm pieces. In other embodiments the pet-ingestible composition mayinclude up to about 0.05%, 0.1%, 0.15%, 0.2%, 0.25%, 0.3%, 0.5% or 1% byweight of the water-soluble film pieces. In some other embodiments, thepet-ingestible composition may include no more than 0.2% by weight ofthe water-soluble film pieces. In an alternative embodiment, thepet-ingestible composition may include no more than 1% by weight of thewater-soluble film pieces.

In some embodiments, the pet-ingestible composition may comprise morethan one type of water-soluble film pieces dispersed within the deliverymatrix. For example, the pet-ingestible composition may include aplurality of a first type of water-soluble film pieces having a firstactive agent and a plurality of a second type of water-soluble filmpieces having a second active agent. The first type of film pieces maybe colored differently from the second type of film pieces and therebyproviding a clear visual distinction to the consumer that thepet-ingestible composition includes more than one type of film piecesfor rapid release of active agents.

The water-soluble film pieces may be in the form of a thin sheet havingany suitable size, thickness and shape. The water-soluble film piecesmay be formed from a composition comprising any film former suitable fororal consumption by an animal, particularly, a dog, a cat or a horse.The term film former may be understood to indicate any material, whichis capable, by itself or with the additional of at least one auxiliaryfilm-forming agent, of forming a continuous film which adheres to asurface and functions as a binder for other components containedtherein. The film formers can be either natural or synthetic and istypically a polymeric material. The film forming polymeric material maycomprise a homopolymer or copolymer, and may be linear, branched orcross-linked. In some embodiments, the film forming polymeric materialmay be elastomeric, and in other embodiments, the film forming polymericmaterial may be thermoplastic.

Typically, the film former may comprise at least one polymer or acopolymer, which may be or may not be cross-linked. In some embodiments,the film former is hydrophilic, and more particularly, may bewater-soluble. In one exemplary embodiment, the film former rapidlydissolves upon contact with a source of water, such as saliva from ananimal's mouth. The film former may also be sufficiently resilient towater such that the film former will not dissolve or soften (e.g., viaabsorption of water from ambient air) upon storage at room temperaturein ambient air for at least three months, six months, or a year. In someembodiments, the film pieces may be sensitive to change in ambienttemperature and relative humidity. For example, the film pieces maydegrade in the presence of oxygen or UV light. Therefore, exemplarycompositions may be packaged in any suitable packaging material forproviding protection during storage, transport, sale and use by theconsumer. In certain exemplary embodiments, the film pieces may also beselected to provide sufficient elasticity and/or resilience such thatthe film pieces are capable of withstanding mixing and/or agitation ofthe film pieces into the delivery matrix. For example, the film piecesmay be capable of withstanding agitation in a mixture for at least 10mins, at least 15 mins, or at least 30 minutes without breaking apart.

In some exemplary embodiments, the film former may comprise one or morewater-soluble polymers. The film former may include a polysaccharide,such as a starch or a gum. For example, the film former may include anatural or synthetic starch (e.g., tapioca starch, potato starch, etc.),a pectin, a natural or synthetic gum (e.g., gum arabic, sodium alginate,etc.), cellulose or a cellulose derivative (e.g., cellulose ether), andcombinations thereof. Suitable starches include, for example, any starchextracted from roots, tubers, grains, seeds, and others, including butnot limited to, wheat starch, corn starch, potato starch, tapiocastarch, rice starch, arrowroot starch, sweet potato starch, pea starch,barley starch, maltodextrin, amylose, high amylose starch, modifiedstarch (e.g., hydroxypropylated high amylose starch), dextrin, levan,elsinan, gluten, etc. In certain embodiments, the film former maycomprise a natural or synthetic gum. Suitable natural gums includesodium alginate, gum arabic, xantham gum, gum acacia, guar gum,pullulan, agar, karaya gum, locust bean gum, carrageenan, Tragacanthaand other gums. Suitable cellulose derivatives may include celluloseethers such as methylcellulose, ethylcellulose, ethyl methyl cellulose,hydroxy ethyl cellulose, hydroypropyl cellulose, hydroxyethyl methylcellulose hydroxypropyl methyl cellulose, ethyl hydroxyethyl cellulose,carboxymethyl cellulose, etc.

In a particular embodiment, the film former may comprise a polymer, inparticular, a polysaccharide. In some embodiments, the polysaccharidemay be cross-linked upon formation of a film. In other embodiments, thepolysaccharide is not cross-linked in the film. In certain exemplaryembodiments, the film former is formed from at least one food-grade filmformer suitable for oral consumption by an animal. In certainembodiments, the film formers are derived from natural sources, e.g.,natural starch from wheat, corn, potato, tapioca, rice, arrowroot, sweetpotato, peas, barley, etc.

In certain embodiment, the film former includes a cellulose, a cellulosederivative (e.g., cellulose ether), or combinations thereof.Specifically, the cellulose and/or cellulose derivative comprise atleast 1% by weight, at least 5% by weight, or at least 10% by weight ofof the film pieces. In other embodiments the cellulose and/or cellulosederivative includes about 1% to about 90% by weight, about 5% to about50% by weight, about 10% to about 40% by weight, about 20% to about 35%by weight, or about 25% to about 30% by weight of the film pieces.

The film pieces further include one or more active agents for impartinga benefit to a pet. The one or more active agents are preferablydispersed throughout the film pieces and encompassed by the film former.The active agents may be particulate and dispersed homogeneouslythroughout the film, or the active agents may be dissolved across thefilm. Suitable active agents are not particularly limited and mayinclude any substance or mixture of substances that impart aphysiological benefit to an animal, particularly a pet, such as a cat, adog or a horse. The active agents may be included in the composition inany physiologically therapeutic effective amounts. Typically, the activeagents comprise from about 5% to about 50% by weight, about 10% to about40% by weight, about 20% to about 35% by weight, or about 25% to about30% by weight of the film pieces. The one or more active agents arepreferably distributed homogenously throughout the plurality of filmpieces such that equally sized film pieces will include approximatelythe same amount of active agents. By approximately the same amount, itis meant within 5%, within 3% within 2% or within 1% of the amount of anactive agent present within a film piece.

In one particular embodiment, the film pieces may comprise active agentssuch as anti-plaque agents, anti-inflammatory agents, anti-tumor agents,anesthetics, breath freshening agents, anti-anxiety agents, energizingagents, weight loss agents, one or more vitamins and/or minerals,nutritional supplements, probiotic compositions, supplements thatprovide a calming effect to a pet, supplements that improves energylevels of a pet, herbal supplements to induce weight loss, starchabsorption blockers, etc. In other embodiments, the active agents may beincorporated into both the delivery matrix and the film pieces. Examplesof suitable active agents include sodium hexametaphosphate, vitamins(e.g., retinol palmitate (vitamin A), thiamine (vitamin B1), riboflavin(vitamin B2), niacin or niacinamide (vitamin B3), pyridoxinehydrochloride (vitamin B6), cyanobalamine (vitamin B12), ascorbic acid(vitamin C), cholecalciferol (vitamin D3), DL-alpha Tocopheryl Acetate(vitamin E), etc.), calcium, phosphorus, potassium, chloride, magnesium,iron, copper, manganese, manganese proteinate, zinc, iodine, niacin,colbalt, glucosamine, glucosamine HCl, N-acetyl-glucosamine, chondroitinsulfate, methylsulfonylmethane, hyaluronic acid, methionine, bromelain,hyaluronic acid, peptides, L-glutathione, L-glutamine, L-carnitine,L-lysine, taurine, biotin, pyridoxine, omega-3, omega-6, chlorophyll,Phaseolus vulgaris, L-theanine, chamomile, fish oil, eicosapentaenoicacid, docosahexaenoic acid, cranberry extract, catnip, Yucca rootextract, diatomaceous earth, sodium bicarbonate, peppermint oil, cloveoil, probiotics (e.g., Bacillus subtilis, Bacillus licheniformis),flavonoid, colostrum, etc. In some embodiments the film pieces may besubstantially free or free of vitamin C. In other embodiments, the filmpieces may be substantially free or free of vitamin B.

In one particular embodiment, the active agents may impart an oral carebenefit, such as anti-plaque formation and breath freshening to the pet.Examples of suitable oral care active agents include Yucca root extract,diatomaceous earth, sodium bicarbonate, sodium hexametaphosphate,peppermint oil, clove oil, and combinations thereof. It is believed thatthe oral care active agents help maintain healthy teeth and gum in thepet, in particular dogs and/or cats. In certain exemplary embodiments,one or more oral care active agents are incorporated into the filmpieces. In other exemplary embodiments, one or more oral care activeagents are incorporated into both the film pieces and the deliverymatrix. The active agents may include particulate materials suitable forabrasion against the surface of the pet's teeth to mechanically removeplaque build-up from the teeth. The abrasive agent may be incorporatedinto the delivery matrix alone or may be incorporated into both thedelivery matrix and the film pieces. In an exemplary embodiments, theabrasive agent comprises from about 0.1 to about 1.0% by weight of thetotal pet-ingestible composition. In other embodiments, the anti-plaqueingredients may include substances believed to impart a whitening effect(e.g., sodium bicarbonate) and/or a tartar prevention effect (e.g.,sodium hexametaphosphate) to the teeth of the pet. The whitening agentmay be from about 0.1% to about 0.5% by weight of the totalpet-ingestible composition. The tartar prevention agent may also be fromabout 0.1% to about 0.5% by weight. The oral care active agents mayfurther include an agent that imparts a breath freshening effect (e.g.,peppermint oil, clove oil, combinations thereof, etc.) to the pet. Thebreath freshening agent may be from about 0.1% to about 0.5% by weight.In one exemplary embodiment, the pet-ingestible composition may comprisea plurality of oral care agents in the following amounts:

% by Weight of Total Active Ingredient Pet-Ingestible Composition YuccaRoot Extract    5-7% Diatomaceous Earth 0.4-0.6% Sodium Bicarbonate0.2-0.3% Sodium Hexametaphosphate 0.2-0.3% Breath freshening agents0.1-0.3%

In an alternative embodiment, the pet-ingestible composition maycomprise a rigid delivery matrix and a plurality of oral care activeagents in the following amounts:

% by Weight of Total Active Ingredient Pet-Ingestible Composition SodiumBicarbonate 0.1-0.5% Sodium Hexametaphosphate 0.1-0.5% Breath fresheningagents 0.1-0.3%In certain exemplary embodiments, compositions having a rigid deliverymatrix may further include an abrasive agent. In other exemplaryembodiments, compositions having a rigid delivery matrix may exclude anabrasive agent. It is believed that the rigidity of the delivery matrixmay be suitable for abrasion against the surface of the pet's teeth tomechanically remove plaque build-up from the teeth.

In another embodiment, the active agents may impart a beneficial effectto the joints of the pet. In certain exemplary embodiments, one or morejoint benefit active agents are incorporated into the film pieces. Inother exemplary embodiments, one or more joint benefit active agents areincorporated into both the film pieces and the delivery matrix. It isbelieved that ingestion of various dietary supplements, such asglucosamine, chondroitin sulfate, methylsulfonylmethane, and/oranti-oxidants may impart a beneficial effect to the joints of the pet.More particularly, it is believed to improve flexibility, reduceinflammation and/or support healthy joint function in pets. It isfurther believed to provide beneficial effects, e.g., relief of symptomsto pets, such as dogs, suffering from arthritis. In an exemplaryembodiments, the joint benefit active agents include glucosamine HCl andchondroitin sulfate. The glucosamine HCl may be obtained from anysuitable source, for example, from shellfish. The chondroitin sulfate iscommonly found in cartilage and may be obtained from any suitablesource, such as porcine cartilage. In a particular exemplary embodiment,glucosamine HCl may be present from about 10% to about 20% by weight ofthe total pet-ingestible composition. The chondroitin sulfate may bepresent from about 5% to about 15% by weight. The pet-ingestiblecompositions may further include additional joint benefit active agents,such as, for example, methylsulfonylmethane, and anti-oxidants (e.g.,hyalurionic acid, maganese, L-glutathione), and combinations thereof.The methylsulfonylmethane may be present from about 1% to about 5% byweight. Anti-oxidants (e.g., hyalurionic acid, maganese, L-glutatione,combinations thereof, etc.) may also be present from about 0.1% to about1% by weight. In one exemplary embodiment, the pet-ingestiblecomposition may comprise a plurality of joint benefit active agents inthe following amounts:

% by Weight of Total Active Ingredients Pet-Ingestible CompositionGlucosamine HCl  15-18% Chondroitin Sulfate  8-12% Methylsulfonylmethane   2-3% Hyalurionic Acid 0.1-0.3% Maganese Proteinate 0.1-0.2%L-Glutathione 0.01-0.05% 

In another embodiment, the active agents may impart a digestive benefitto the pet. The digestive agents may include a probiotic compositioncontaining live (viable) naturally occurring microorganisms and/or otherdigestive aids. In certain exemplary embodiments, one or more digestiveagents are incorporated into the film pieces. In other exemplaryembodiments, one or more digestive agents are incorporated into both thefilm pieces and the delivery matrix. It is believed that ingestion ofcertain microorganisms, such as probiotic bacterium, may impart abenefit, particularly a gastrointestinal benefit, to the pet, such as adog or a cat. The probiotic agents may include any suitable bacteriumthat imparts a beneficial effect to a pet, particularly to a dog or acat. More particularly, the probiotic agent may include any suitablebacterium that imparts a gastrointestinal benefit, such as, for example,improve digestion or relief from gastrointestinal discomfort,particularly for a dog. For example, the probiotic agents may includeBacillus subtilis (e.g., in the form of a dried Bacillus subtilisfermentation product), Bacillus licheniformis (e.g., in the form of adried Bacillus licheniformis fermentation product), or combinationsthereof. In certain exemplary embodiments, each pet chew composition mayinclude at least 200 million, at least 1 billion, at least 2 billion, orat least 3 billion colony forming units (CFUs) of microrganisms. In aparticular embodiment, each pet chew composition may include at least 2billion CFUs of Bacillus subtilis in combination with Bacilluslicheniformis. In an alternative exemplary embodiment, at least 200million CFUs of microorganisms, preferably Bacillus subtilis incombination with Bacillus licheniformis, may be included in each 35 mgpet chew. The probiotic agents may be incorporated only in the filmpieces, only in the delivery matrix, or in both the film pieces and thedelivery matrix. The digestive agents may further include otherdigestive aids such as, compositions that promote growth of beneficialbacteria in the gastrointestinal track of the pet, for example, inulin.The digestive aids (e.g., inulin) may be incorporated only in the filmpieces or in both the film pieces and the delivery matrix.

In another embodiment, the active agents may impart a calming effect tothe pet, particularly to a dog or a cat. It is believed that ingestionof various dietary supplements may impart a calming effect to the pet,particularly a dog or a cat. In particular, the calming agents arebelieved to reduce the impact of increased environmental stressors. Moretypically, the calming agents are believed to reduce anxiety,nervousness, hyperactivity, frayed nerves, excess barking, abnormalurine marking, trembling, shivering, destructive behavior and/oraggressive behavior in a dog. The calming agents are believed to assistthe pet, particularly dog or cat, achieve an alert state of relaxationwithout a drowsy effect. Examples of suitable claming agents includeflavonoid, colostrum, B vitamins (e.g., Thiamine (Vitamin B1), Niacin(Vitamin B3), Pyridoxine (Vitamin B6), Vitamin B12, etc.), L-Theanine(e.g., Suntheanine® brand), chamomile, and combinations thereof. Incertain exemplary embodiments, the calming agents are incorporated intothe film pieces. In other exemplary embodiments, the calming agents areincorporated into both the film pieces and the delivery matrix. Thecalming agents may include a combination of flavonoid and colostrum,e.g., commercially available mixture blend of flavonoid and colostrumknown as FlavoCol™. The combination of flavonoid and colostrum may bepresent from about 0.5% to about 3% by weight of the totalpet-ingestible composition. The calming agents may include one or more Bvitamins. The B vitamins (e.g., Thiamine (Vitamin B1), Niacin (VitaminB3), Pyridoxine (Vitamin B6), Vitamin B12, etc.) may be present fromabout 0.05% to about 1% by weight of the total pet-ingestiblecomposition. The calming agents may also include L-theanine (e.g.,Suntheanine® brand) from about 0.1% to about 1% by weight. The calmingagent may further include chamomile (e.g., Matricaria perforata powder)from about 0.1% to about 1% by weight. In some embodiments, the calmingagents do not include L-tryptophan, and in specific exemplaryembodiments, the pet-ingestible composition may be free or substantiallyfree of L-tryptophan. In one exemplary embodiment, the pet-ingestiblecomposition may comprise a plurality of calming agents in the followingamounts:

% by Weight of Total Active Ingredient Pet-Ingestible CompositionFlavonoid and Colostrum (FlavoCol ™)    1-2% Niacin (Vitamin B3)0.2-0.5% L-Theanine (Suntheanine ® brand) 0.1-0.3% Chamomile (Matricariaperforata) 0.1-0.3% Powder Thiamine (Vitamin B1) 0.1-0.2% Pyridoxine(Vitamin B6) 0.01-0.04%  Vitamin B12 0.0001-0.001%   

In an alternative embodiment, the pet-ingestible composition maycomprise a plurality of calming agents in the following amounts:

% by Weight of Total Active Ingredient Pet-Ingestible CompositionFlavonoid and Colostrum (FlavoCol ™)    1-2% Niacinamide 0.5-1.5%L-Theanine (Suntheanine ® brand) 0.3-0.7% Chamomile (Matricariaperforata) 0.1-0.3% Powder Thiamine (Vitamin B1) 0.1-0.2% Pyridoxine(Vitamin B6) 0.01-0.04%  Vitamin B12 0.0001-0.001%   

In a further embodiment, the active agents may control the weight (e.g.,inhibit weight gain and/or induce weight loss) of a pet. In certainexemplary embodiments, one or more weight control active agents areincorporated into the film pieces. In other exemplary embodiments, oneor more weight control active agents are incorporated into both the filmpieces and the delivery matrix. It is believed that ingestion of variousdietary supplements, such as phaseoulus vulgaris, L-taurine, and/orcertain other amino acids and minerals may inhibit weight gain or induceweight loss in a pet. In an exemplary embodiments, weight control activeagents include phaseoulus vulgaris and/or L-taurine. In a particularembodiment, phaseoulus vulgaris may be present from about 0.5% to about5% by weight of the total pet-ingestible composition. The L-taurine maybe present from about 0.001% to about 0.01% by weight. Thepet-ingestible compositions may further include additional weightcontrol active agents, such as, for example, L-glutamine, L-carnitine,L-lysine, manganese, thiamine and combinations thereof. In one exemplaryembodiment, the pet-ingestible composition may comprise a plurality ofweight control active agents in the following amounts:

% by Weight of Total Active Ingredients Pet-Ingestible CompositionPhaseoulus Vulgaris    1-3% L-Glutamine   0.1-0.5% L-Carnitine 0.01-0.1% L-Lysine  0.01-0.1% L-Taurine 0.001-0.01% Maganese0.001-0.01% Thiamine 0.0005-0.005% 

In another embodiment, the pet-ingestible composition may comprise filmpieces having one or more vitamin, mineral and/or nutritionalsupplements. The pet-ingestible composition may comprise proteinsupplements such as yogurt powder, dried whey, and/or whey concentrate.In certain exemplary embodiments, one or more vitamin, mineral and/ornutritional supplements are incorporated into the film pieces. In otherexemplary embodiments, one or more vitamin, mineral and/or nutritionalsupplements are incorporated into both the film pieces and the deliverymatrix. In one exemplary embodiment, the pet-ingestible composition maycomprise a plurality of vitamin, mineral and/or nutritional supplementsin the following amounts:

% by Weight of Total Active Ingredients Pet-Ingestible CompositionPotassium  0.05-0.1% Chloride  0.03-0.1% Magnesium 0.001-0.01% Thiamine0.001-0.01% Riboflavin 0.001-0.01% Niacin 0.005-0.02% Pyridoxine0.001-0.01% Ascorbic Acid  0.05-0.2% Omega 3 Fatty Acids   0.1-0.5%Omega 6 Fatty Acids  0.05-0.2%Furthermore, the composition may comprise at least 1 IU of Vitamin E per1 to 2 grams of the pet ingestible composition.

In certain embodiments, the film pieces may include a coloring agent.The coloring agent may be visibly different from the color of thedelivery matrix. More particularly, the film pieces may be colored toprovide significant contrast between the film pieces and the deliverymatrix, for example, the film pieces may include a coloring agent thatimparts a vibrant color and in contrast, the delivery matrix may be asubdued light color. For example, the film pieces may include coloringagents that impart a red or orange color, which may be placed incontrast to a light color, e.g., white or off-white delivery matrix. Anysuitable coloring agent that may be orally administered to an animal maybe used. In some embodiments, the coloring agent is a food gradecoloring additive. In another embodiment, the coloring agent includesSpirulina, red cabbage juice and/or other naturally occurring pigments.For example, the coloring agents may include FD&C Blue No. 1 (disodiumsalt of ethyl [4-[p-[ethyl (m-sulfobenzyl) amino]-a-(o-sulfophenyl)benzylidene]-2,5-cyclohexadien-1-ylidene] (m-sulfobenzyl) ammoniumhydroxide), FD&C Blue No. 2 (disodium salt of2-(1,3-dihydro-3-oxo-5-sulfo-2H-indol-2-ylidene)-2,3-dihydro-3-oxo-1H-indole-5-sulfonicacid (CAS Reg. No. 860-22-0)), FD&C Green No. 3 (disodium salt ofN-ethyl-N-[4-[[4-[ethyl[(3-sulfophenyl)methyl]amino]phenyl](4-hydroxy-2-sulfophenyl)methylene]-2,5-cyclohexadien-1-ylidene]-3-sulfobenzenemethanaminiumhydroxide (CAS Reg. No. 2353-45-9)), Orange B (disodium salt of1-(4-sulfophenyl)-3-ethylcarboxy-4-(4-sulfonaphthylazo)-5-hydro-xypyrazole),Citrus Red No. 2 (1-(2,5-dimethoxyphenylazo)-2-naphthol), FD&C Red No. 3(monohydrate of 9(o-carboxyphenyl)-6-hydroxy-2,4,5,7-tetraiodo-3H-xanthen-3-one, disodiumsalt), FD&C Red No. 40 (disodium salt of6-hydroxy-5-[(2-methoxy-5-methyl-4-sulfophenyl)azo]-2-naphthalenesulfonicacid), FD&C Yellow No. 5 (trisodium salt of4,5-dihydro-5-oxo-1-(4-sulfophenyl)-4-[4-sulfophenyl-azo]-1H-pyrazole-3-carboxylicacid (CAS Reg. No. 1934-21-0)), FD&C Yellow No. 6 (disodium salt of6-hydroxy-5-[(4-sulfophenyl)azo]-2-naphthalenesulfonic acid (CAS Reg.No. 2783-94-0)), amongst others, and combinations thereof.

In some embodiments, the film pieces may include one or more dietaryfibers, such as a natural fiber, e.g., oat fiber, wheat fiber, etc. Inother embodiments, the film pieces may be free of dietary fibers. It isbelieved that the addition of dietary fibers to the film pieces mayreduce the concentration of color, and thereby mute the coloring. Thus,to maintain vibrant coloring of the film pieces, dietary fiber may beexcluded. In some examples, the film pieces may be free or substantiallyfree of dietary fibers. By substantially free it is meant that the filmpieces may include small traces of dietary fiber that it does not causeany noticeable degradation of color appearance to the film pieces. Incertain embodiments, the film pieces may also be translucent orsemi-translucent.

The film pieces may further comprise a humectant, an emulsifier, athickener, a lubricant, a sweetener, a surfactant, etc. Suitablehumectants may include propylene glycol, glycerol, sugar alcohols (e.g.,sorbitol, xylitol, maltitol), etc. Additionally, suitable emulsifiersmay include polysorbate, polyethylene glycol, etc. In one exemplaryembodiment, the film pieces may comprise a polysaccharide (e.g., tapiocastarch), a natural gum (e.g., sodium alginate), a humectant (e.g.,glycerin), an emulsifier (e.g., polysorbate), flavoring agents, andsweeteners. In one specific embodiment, the film pieces are formed froma composition comprising glycerin, flavoring agents, polysorbate, sodiumalginate, sorbitol, sorbitan ester, sucralose, tapioca starch, water,and one or more active agents.

In one specific embodiment, the film pieces include a combination ofhydroxypropyl methylcellulose, glycerin, Spirulina and one or moreactive agents. In another embodiment, the film pieces include acombination of hydroxypropyl methylcellulose, glycerin, red cabbagejuice, sodium bicarbonate and one or more active agents. In a furtherembodiment, the film pieces consist essentially of or consists of acombination of hydroxypropyl methylcellulose, glycerin, Spirulina, andone or more active agents. In an even further embodiment, the filmpieces consist essentially of or consists of a combination ofhydroxypropyl methylcellulose, glycerin, red cabbage juice, sodiumbicarbonate and one or more active agents.

Upon contact with a water source, such as saliva from a pet, the filmpieces may quickly dissolve and rapidly release the active agents intothe surrounding environment. In some exemplary embodiments, the filmpieces may fully dissolve in less than about 30 seconds, less than about10 seconds, less than about 5 seconds, when placed in contact withsaliva from the mouth of the pet.

The water-soluble film pieces may be in any suitable size and shape fordispersing in the delivery matrix and oral delivery to a pet. Inparticular, the water-soluble film pieces may have any suitablethickness for rapid dissolution upon contact with saliva from the pet.However, the film pieces may also be sufficiently thick that thewater-soluble film pieces will not dissolve, bleed color into thedelivery matrix, or soften upon storage at room temperature for at leastthree months, six months, a year, or two years.

In one exemplary embodiment, the film pieces may be uniformly sized andshaped. The film pieces may have any suitable shape, such as anirregular shape or any geometric shape. For example, the film pieces maybe in the shape of a polygon, such as triangle, quadrilateral (e.g.,square, rectangle, trapezoid, etc.) pentagon, hexagon heptagon, octagon,etc., a circle, an oval, an ellipse, etc. The film pieces may be of anysuitable size for oral administration to a pet. Furthermore, the filmpieces may be suitably sized for incorporation into the delivery matrixwithout folding the film pieces onto itself. The film pieces may also besuitably sized so that the film pieces do not substantially overlappingwith each other as they are dispersed within the delivery matrix, andthus, prevent aggregation of the film pieces within the composition. Ina particular exemplary embodiment, the film pieces may be suitably sizedand shaped such that when the film pieces are homogeneously dispersedthroughout the delivery matrix, the film pieces do not come in contactwith each other. In one exemplary embodiment, the film pieces may have alongest dimension from about 1/64 inch to about ⅜ inch, from about 1/32inch to about ¼ inch, or from about 1/16 inch to about ⅛ inch. In oneparticular embodiment, the film pieces are in a rectangular shape. Theratio of the width to the length of the rectangular shape may be fromabout 1:1 to about 1:10, from about 1:1.5 to about 1:8, from about 1:2to about 1:6.

The film pieces may be formed by first preparing a sheet of the filmforming material encompassing the one or more active agents by anysuitable means. Preferably, the active agents are homogenouslydistributed throughout the sheet of the film forming material. The sheetmay be subsequently cut to formed film pieces of any desired shape. Forexample, the sheet of film forming material may be cut using a cutter ora die, or otherwise shaped to smaller film pieces having the desiredshape.

The pet-ingestible composition also includes a delivery matrixencompassing the plurality of film pieces containing one or more activeagents. The delivery matrix may include any suitable pet product to beorally consumed by an animal, more particularly, a dog, a cat, or ahorse. Exemplary embodiments of the delivery matrix may include achewable or non-chewable treat or kibble. In a particular embodiment,the delivery matrix has a soft, chewable texture. In other embodiments,the delivery matrix is the form of a rigid pellet, such as that in petkibble. The treat or kibble may be formulated for a dog, a cat, a horse,or any other animal. For example, the pet treat or kibble may comprise ahigh-protein base ingredient, such as yogurt powder or whey proteinconcentrate, providing nutrients to the pet. In another embodiment, thepet-ingestible composition may be in the form of a chewable bar. Thechewable bar may be sized and shaped to be suitable for consumption by adog in multiple bites. For example, the chewable bar may have adimension of approximately 4.5 inches long, from about 1 to about 1.5inches wide, and from about 0.5 to about 0.75 inches thick. In oneexample, each bar may weight at or approximately 35 grams. In a furtherembodiment, the delivery matrix may be rigid. Preferably, the deliverymatrix is sufficiently rigid that the rigidity of the delivery matrix issuitable for abrasion against the surface of the pet's teeth tomechanically remove plaque build-up from the teeth. In one embodiment,the rigid pet-ingestible composition may have an elongate shape. Forexample, the elongated shaped may have a uniform or different crosssection along the length of the pet-ingestible composition. In certainembodiments, the pet-ingestible composition may be cylindrical (e.g.,having a uniform cross section). In other embodiments, thepet-ingestible composition may have a cross-section of any suitablegeometric shape (e.g., triangle, rectangle, square, pentagon, hexagon,octagon, etc.). In another example, the rigid pet-ingestible compositionmay have a tubular shape. The rigid pet-ingestible compositions may besuitable as a dental stick for continuous chewing by a pet (e.g., dog).In some exemplary embodiments, the rigid pet-ingestible composition maybe from about 1.5 to about 5 inches in length. The exemplary rigidpet-ingestible composition may have a width or a diameter of no morethan 1.25 inches. Each rigid pet-ingestible composition may weight fromabout 10 grams to about 30 grams.

Typically, the pet-ingestible composition includes at least 5% by weightof crude protein, at least 8% by weight of crude protein, at least 15%by weight of crude protein, at least 25% by weight of crude protein,from about 5% to about 70% by weight of crude protein, or from about 8%to about 50% by weight of crude protein. The protein may be sourced froma variety of natural sources (e.g., yogurt, chicken, beef, liver, fish,whey, etc.). In some embodiments, the pet-ingestible composition mayinclude at least 5% crude fat, or at least 10% crude fat. In addition,the pet-ingestible composition may include crude fiber. Preferably, theamount of crude fiber in each pet-ingestible composition is less than3%.

In one exemplary embodiment, the pet-ingestible composition includes atleast 2% by weight of yogurt powder, at least 3% by weight of yogurtpowder, at least 5% by weight of yogurt powder, at least 7% by weight ofyogurt powder, at least 10% by weight of yogurt powder, from about 2% toabout 10% yogurt powder, from about 3% to about 7% yogurt powder, fromabout 7% to about 90% yogurt powder, from about 10% to about 70% yogurtpowder, from about 10% to about 25% yogurt powder, or from about 15% toabout 20% yogurt powder. It is believed that the inclusion of yogurtpowder in a yogurt-based delivery matrix provides increasedbioavailability of active agents to the pet. Specifically, it isbelieved that the yogurt provides a faster dissolving chewablecomposition as compared to other pet chew compositions and therebyreleasing a larger amount of active ingredients to the mouth fororomucosal delivery. In certain exemplary embodiments, the yogurt-basedmatrix may be rapidly dissolving thereby releasing at least a portion ofthe active ingredients upon ingestion, before the composition reachesthe stomach for further digestion. More particularly, the yogurt-basedmatrix may be soft and chewable, and is also preferably crumbly andeasily dissolvable upon mixing with saliva in the pet's mouth. In someembodiments, the pet-ingestible composition is soft and chewy, but issufficiently malleable and resilient to allow the pet to repeatedly chew(e.g., to chew at least twice or thrice before swallowing) the chewablecomposition and expose more film pieces to saliva from the pet's mouth.

In an another embodiment, the pet-ingestible composition may include atleast 16% by weight of whey protein concentrate, at least 28% by weightof whey protein concentrate, from about 16% to about 90% yogurt powder,more typically, from about 25% to about 70% yogurt powder, from about28% to about 60%, or from about 30% to about 55%.

In some embodiments, the delivery matrix may include a bulking agent, abinding agent, a flavoring agent, a preservative agent and/or an activeingredient for oral delivery to a pet. Any suitable bulking agent may beincluded in the delivery matrix, for example, the delivery matrix mayinclude grain meals or flours (e.g., wheat flour, corn meal, rice flouretc.), cellulose, methylcellulose, amongst others. The delivery matrixmay also include any suitable binding agents, such as edible oils (e.g.,vegetable oil, fish oil), gelatin, yogurt, etc. Typically, the deliverymatrix includes a flavoring agent that is pleasing to an animal,particularly to a dog, a cat or a horse. The flavoring agent may be anysuitable flavoring additive that is palatable and desirable forconsumption by a dog, a cat or a horse. Typically, the flavoring agentsprovide a scent or taste that attracts the dog, cat or horse to consumethe composition. For example, the flavoring agent may include mintflavoring, smoke flavoring, bacon flavoring, fish flavoring, chicken,beef, liver, etc. In one exemplary embodiment, the delivery matrix mayinclude flavoring agents such that the composition is palatable to dogs.For example, the delivery matrix may include flavoring agents such thatit at least 80% palatable to dogs, meaning 80% of dogs given thecomposition will readily consume the composition. In other embodiments,the delivery may include flavoring agents such that it is at least 90%palatable to dogs or at least 95% palatable to dogs. In otherembodiments the delivery matrix may include flavoring agents such thatit is at least 80% palatable to cats, at least 90% palatable to cats, orat least 95% palatable to cats. In one exemplary embodiment, the pettreat may include a breath freshening agent and a flavoring agent suchthat the breath freshening agent does not mask the flavoring agent andthat the delivery matrix remains at least 80% at least 90% palatable orat least 95% palatable to a dog or a cat. The delivery matrix may alsoinclude any suitable active agent, such as vitamins, nutritionalsupplements, herbal remedies, pharmaceutical agents, and the like, asdescribed above. In some embodiments, the pet treat composition may besubstantially free of or free of meat byproducts, artificial flavors,and/or artificial colors. In other embodiments, the chewable pet treatmay be gluten-free and/or grain-free.

In certain embodiments, the delivery matrix has a water-content suitablefor mixing with the water-soluble film pieces, such that the film piecesdo not dissolve and/or aggregate within the composition. In oneexemplary embodiment, the film pieces may include a vibrant coloringagent. Thus, the delivery matrix may have a moisture level that does notpermit the coloring agent to leech from the film pieces and into thedelivery matrix. For example, the delivery matrix may have a moisturelevel (e.g., amount of water present) of less than or equal to 25%, lessthan or equal to 20%, less than or equal to 18%, less than or equal to15%, less than or equal to 14%, or less than or equal to 10%.

In a particular exemplary embodiment, the delivery matrix may comprisecomprising yogurt powder, dried whey, glycerin, lecithin, maltodextrin,natural chicken flavor, potato flour, potato starch, salt, soybean oil,tapioca starch, and/or preservatives (e.g., lactic acid, mixedtocopherols, rosemary, and/or sorbic acid). In one specific embodiment,the delivery matrix comprises a combination of yogurt powder androsemary (or rosemary extract), which is believed to act as apreservative. In some exemplary embodiments, the delivery matrix maycomprise at least 8% by weight crude protein, at least 10% by weightcrude fat, at most 3% by weight of crude fiber, and/or at most 14%moisture.

In another exemplary embodiment, the delivery matrix may comprise potatostarch, dried whey, glycerine, potato flour, sunflower lecithin, driedyogurt, flaxseed, and/or preservatives (e.g., sorbic acid and/orphosphoric acid). In some exemplary embodiments, the delivery matrix maycomprise at least 15% by weight crude protein, at least 5% by weightcrude fat, at most 3% by weight of crude fiber, and/or at most 20%moisture.

In some exemplary embodiments, the delivery matrix may be prepared bycombining and agitating the ingredients of the delivery matrix to form asubstantially homogenously or homogeneous mixture. Typically, thismixture may be prepared in a hopper, a drum, or any other suitableequipment for distributing each ingredient of the delivery matrixformulation homogenously throughout. After the delivery matrix is wellmixed, the film pieces may be added to the delivery matrix formulationmixture and the mixture is further agitated until the film pieces arehomogenously distributed throughout the delivery matrix mixture. Anysuitable speed and amount of time for mixing and agitating the mixturemay be used. In particular, after the film pieces are added to thedelivery matrix mixture the speed and amount of time for mixing andagitating may be selected to so as to prevent breakdown of the filmpieces and preserve the original size and shape of the film pieces.

The mixture, including the film pieces, may be placed into an extruderand extruded to any suitable size and shape. To preserve the structureof the film pieces, the delivery matrix is preferably cold extrudedusing any suitable process. In one particular embodiment, thecomposition may be formed, e.g., extruded to arrive at uniformly shapedand sized solid formulations having a size suitable for oraladministration to a pet, such as a dog, a cat, or a horse, such that itis safe for the pet to ingest. In particular, the pet-ingestiblecompositions may be sized to be of a sufficiently large size so that itdoes not pose a choking hazard to the pet. In other embodiments, thepet-ingestible composition is larger than at least a tooth of the petsuch that it is sized for repeat chewing by the pet. In anotherexemplary embodiment, the composition may be a pet chew extruded to havea weight from about 2 grams to 8 grams, or from 3 grams to 5 grams, orapproximately 4 grams.

Alternatively, the delivery matrix mixture may be extruded using aheated process to any suitable size and shape, in particular, in theshape of a bar or a stick. For example, the delivery matrix may beformed into a chewable bar. The chewable bar may be sized and shaped tobe suitable for consumption by a dog in multiple bites. In one example,each bar may weight at or approximately 35 grams. In another example,the chewable bar may have a dimension of approximately 4.5 inches long,from about 1 to about 1.5 inches wide, and from about 0.5 to about 0.75inches thick. In a further embodiment, the delivery matrix mixture maybe formed into an elongated shape. In some exemplary embodiments, theelongated shape may have a length from about 1.5 to about 5 inches. Theexemplary rigid pet-ingestible composition may have a width or adiameter of no more than 1.25 inches. Each pet-ingestible compositionhaving an elongated shape may weight from about 10 grams to about 30grams. In some embodiments, the extruded delivery matrix mixture may berigid, such as a dental stick for continuous chewing by a pet (e.g.,dog). The delivery matrix may be hot extruded using any suitableprocess. In certain embodiments, the temperature at which the hotextrusion is conducted does not denature the proteins within thedelivery matrix mixture or cause degradation of (e.g., melting, changingcolor, leeching coloring agents from) the film former pieces. In oneparticular embodiment, the delivery matrix is hot extruded using aprocess that heats the delivery matrix mixture to a temperature nogreater than 284° F. or 140° C. for no more than about 6 to about 8seconds. The delivery matrix mixture is forced through an opening in adie to form an elongated shape. The elongated shape may subsequently becut to a desired length (e.g., from about 1.5 to about 5 inches),typically, as the extruded mixture leaves the die. In one particularembodiment, the composition may be formed, e.g., extruded to arrive atuniformly shaped and sized solid formulations having a size suitable fororal administration to a pet, such as a dog, a cat, or a horse, suchthat it is safe for the pet to ingest. In particular, the pet-ingestiblecompositions may be sized to be of a sufficiently large size so that itis larger than the size of the pet's mouth. In particular, thepet-ingestible composition is sized and shaped such that the entirecomposition does not fully fit within the pet's mouth and that repeatedbites or chewing is necessary for the pet to consume the entirecomposition. More particularly, the composition may be formed into achewable bar that is extruded, typically using a hot-extrusion process,to have a weight from about 20 grams to 40 grams, or approximately 35grams. In another embodiment, the delivery matrix mixture may beextruded, typically using a hot-extrusion process, into a rigidcomposition having an elongated shape (e.g., a stick).

The pet-ingestible compositions of the present invention provides twostep delivery of active agents to a pet (e.g., a dog, a cat or a horse):(1) initial rapid release and oromucosal delivery of the active agents;and (2) subsequent absorption of additional active agents via thegastrointestinal track. It is believed that this two step deliveryprovides improved delivery and/or availability of active agents to thepet.

First, the pet-ingestible composition of the present invention allowsfor delivery of active agents to the pet without significant force orstruggle. The pet owner may simply offer the composition to the pet, andthe pet may voluntarily consume and chew on the composition. Once thepet-ingestible composition is orally administered to the pet, salivafrom the pet's mouth may come in contact with the film pieces andrapidly dissolve the film pieces, and thus rapidly releasing the activeagents into the pet's mouth. In embodiments where the delivery matrix isa chewable formulation, the pet may continue to chew on the compositionand thereby exposing film pieces located within the interior of thecomposition to the saliva of the pet and causing further dissolution ofthe film pieces and additional release of the active agents into thepet's mouth. The released active agents may be swallowed andsubsequently absorbed by the pet through its gastrointestinal track. Insome embodiments, the released active agents may also be oromucosallyabsorbed by the mouth of the pet. In other embodiments, the releasedactive agents act within the pet's mouth, for example, an anti-plaqueagent may impart a benefit to the teeth of the pet.

Secondly, the film pieces allow for an initial rapid release andoromucosal delivery of the active agent so that the active agent may bemore rapidly absorbed by the pet. It is believed that the initial rapidrelease and oromucosal delivery may improve the overall absorption ofthe active agents by the pet. Specifically, oromucosal absorption ofcertain nutritional supplements are believed to be 9 times moreeffective than absorption of the same supplements via thegastrointestinal track. (See Ghodake et al., “Mouth Dissolving Films:Innovative Vehicle for Oral Drug Delivery,” International Journal ofPharma Research & Review, 2(10): 41-47 (October 2013, which isincorporated by reference herein)). Therefore, the initial release ofactive agents from the film formers and into the mouth of the pet mayprovide faster absorption and increased availability of the activeagents to the pet.

Example I: An Exemplary Dog Oral Care Composition

In one exemplary embodiment, the pet treat composition may be useful forimparting a dental benefit to the dog, particularly the pet treatcomposition may be chewable and include one or more oral care activeagents that may impart an anti-plaque, whitening and/or breathfreshening effect to the pet. The chewable pet treat composition mayalso include a flavoring agent and is palatable to a dog. In aparticular exemplary embodiment, the pet treat composition isapproximately 4 grams and may include active ingredients in thefollowing amounts:

Amounts in 4 g Active Ingredients Chewable Pet Treat Composition YuccaRoot Extract 25 mg Diatomaceous Earth 20 mg Sodium Bicarbonate 10 mgSodium Hexametaphosphate 10 mg Peppermint Oil 5 mg Clove Oil 3 mg

The remainder of the weight may comprise inactive ingredients, such as,yogurt flour, whey, glycerin, lactic acid, lecithin, maltodextrin, mixedtocopherols, natural chicken flavor, potato flour, potato starch,rosemary, salt, soybean oil, sorbic acid, Spirulina, and tapioca starch.In some examples, Spirulina may be replaced with red cabbage juice,which may be used with or without sodium bicarbonate. The chewable pettreat composition may include at least 8% by weight of crude protein, atleast 10% by weight of crude fat, at most 3% by weight of crude fiber,and at most 14% by weight of moisture.

Example II: An Alternative Exemplary Dog Oral Care Composition

In an alternative exemplary embodiment, a pet ingestible compositioncomposition may imparting a dental benefit to the dog, particularly thecomposition may include one or more oral care active agents that mayimpart an anti-plaque, whitening and/or breath freshening effect to thepet. The delivery matrix may be rigid and have an elongated shape.Preferably, the delivery matrix is sufficiently rigid that the rigidityof the delivery matrix is suitable for abrasion against the surface ofthe pet's teeth to mechanically remove plaque build-up from the teeth.The pet ingestible composition may also include a flavoring agent and ispalatable to a dog. In a particular exemplary embodiment, the petingestible composition is from about 10 grams to about 30 grams inweight and may comprise potato starch, glycerin, dried yogurt, potatoflour, sunflower lecithin, natural chicken flavor, lactic acid, sodiumbicarbonate, sorbic acid, peppermint oil, riboflavin supplement, cloveoil, and sodium hexametaphosphate. The pet ingestible composition mayinclude at least 5% by weight of crude protein, at least 5% and at most9% by weight of crude fat, at most 2% by weight of crude fiber, and atmost 18% by weight of moisture.

Example III: An Exemplary Dog Joint Health Composition

In one exemplary embodiment, the pet treat composition may be useful forimparting a benefit to the joints of a dog, particularly the pet treatcomposition may be chewable and include one or more active agents thatmay impart a beneficial effect to the joints of a dog. The chewable pettreat composition may also include a flavoring agent and is palatable toa dog. In a particular exemplary embodiment, the pet treat isapproximately 4 grams and may include active ingredients in thefollowing amounts:

Amounts in 4 g Active Ingredients Chewable Pet Treat CompositionGlucosamine HCl 650 mg Chondroitin Sulfate 400 mg Methylsulfonylmethane100 mg Hyalurionic Acid 10 mg Maganese Proteinate 5 mg L-Glutathione 2mg

The remainder of the weight may comprise inactive ingredients, such as,yogurt flour, whey, glycerin, lactic acid, lecithin, maltodextrin, mixedtocopherols, natural chicken flavor, potato flour, potato starch,rosemary, salt, soybean oil, sorbic acid, Spirulina, and tapioca starch.In some examples, Spirulina may be replaced with red cabbage juice,which may be used with or without sodium bicarbonate. The chewable pettreat composition may include at least 8% by weight of crude protein, atleast 10% by weight of crude fat, at most 3% by weight of crude fiber,and at most 14% by weight of moisture.

Example IV: An Exemplary Dog Probiotic Composition

In one exemplary embodiment, the pet treat composition may be useful forimparting a digestive benefit to a dog, particularly the pet treatcomposition may be chewable and include one or more active digestiveagents that may impart a digestive benefit to a dog. Specifically, thedigestive agents may include probiotic bacterium and inulin. Theprobiotic bacterium may be Bacillus subtilis (e.g., in the form of adried Bacillus subtilis fermentation product), Bacillus licheniformis(e.g., in the form of a dried Bacillus licheniformis fermentationproduct), or combinations thereof. In a particular exemplary embodiment,the pet treat is approximately 4 grams and may include at least 2billion CFUs Bacillus subtilis in combination with Bacilluslicheniformis and 200 mg of inulin. The remainder of the weight maycomprise inactive ingredients, such as, yogurt flour, whey, glycerin,lactic acid, lecithin, maltodextrin, mixed tocopherols, natural chickenflavor, potato flour, potato starch, rosemary, salt, soybean oil, sorbicacid, Spirulina, and tapioca starch. In some examples, Spirulina may bereplaced with red cabbage juice, which may be used with or withoutsodium bicarbonate. The chewable pet treat composition may include atleast 8% by weight of crude protein, at least 10% by weight of crudefat, at most 3% by weight of crude fiber, and at most 14% by weight ofmoisture.

Example V: An Alternative Exemplary Dog Probiotic Composition

In an alternative exemplary embodiment, a pet ingestible bar compositioncomposition may be useful for imparting a digestive benefit to a dog,particularly the pet ingestible bar composition may be chewable andinclude one or more active digestive agents that may impart a digestivebenefit to a dog. Specifically, the digestive agents may includeprobiotic bacterium and inulin. The probiotic bacterium may be Bacillussubtilis (e.g., in the form of a dried Bacillus subtilis fermentationproduct), Bacillus licheniformis (e.g., in the form of a dried Bacilluslicheniformis fermentation product), or combinations thereof. In aparticular exemplary embodiment, the pet ingestible bar composition isapproximately 35 grams and may include at least 200 million CFUsBacillus subtilis in combination with Bacillus licheniformis and 1500 mgof inulin. The pet ingestible bar composition may further include atleast 50 mg of Omega 3 fatty acids and/or at least 20 mg of Omega 6fatty acids. The remainder of the weight may comprise inactiveingredients, such as, potato starch, whey protein concentrate, glycerin,potato flour, dried yogurt, sunflower lecithin, flaxseed meal, naturalchicken flavor, sorbic acid and phosphoric acid. The pet ingestible barcomposition may include at least 15% by weight of crude protein, atleast 5% by weight of crude fat, at most 3% by weight of crude fiber,and at most 20% by weight of moisture.

Example VI: An Exemplary Dog Calming Composition

In another exemplary embodiment, the pet treat composition may be usefulfor imparting a calming effect to a dog, particularly the pet treatcomposition may be chewable and include one or more calming agents thatmay reduce anxiety, nervousness, hyperactivity, frayed nerves, excessbarking, abnormal urine marking, trembling, shivering, destructivebehavior and/or aggressive behavior in a dog. The chewable pet treatcomposition may also include a flavoring agent and is palatable to adog. In a particular exemplary embodiment, the pet treat isapproximately 4 grams and may include active ingredients in thefollowing amounts:

Amounts in 4 g Active Ingredients Chewable Pet Treat CompositionFlavonoid and Colostrum (FlavoCol ™) 60 mg Niacin (Vitamin B3) 13 mgL-Theanine (Suntheanine ® brand) 10 mg Chamomile (Matricaria perforata)10 mg Powder Thiamine (Vitamin B1) 6 mg Pyridoxine (Vitamin B6) 1 mgVitamin B12 2.4 mcg

The remainder of the weight may comprise inactive ingredients, such as,yogurt flour, whey, glycerin, lactic acid, lecithin, maltodextrin, mixedtocopherols, natural chicken flavor, potato flour, potato starch,rosemary, salt, soybean oil, sorbic acid, Spirulina, and tapioca starch.In some examples, Spirulina may be replaced with red cabbage juice,which may be used with or without sodium bicarbonate. The chewable pettreat composition may include at least 8% by weight of crude protein, atleast 10% by weight of crude fat, at most 3% by weight of crude fiber,and at most 14% by weight of moisture.

Example VII: An Alternative Exemplary Dog Calming Composition

In another exemplary embodiment, a pet ingestible bar composition may beuseful for imparting a calming effect to a dog, particularly the petingestible bar composition may be chewable and include one or morecalming agents that may reduce anxiety, nervousness, hyperactivity,frayed nerves, excess barking, abnormal urine marking, trembling,shivering, destructive behavior and/or aggressive behavior in a dog. Thepet ingestible bar composition may also include a flavoring agent and ispalatable to a dog. In a particular exemplary embodiment, the petingestible bar composition is approximately 35 grams and may includeactive ingredients in the following amounts:

Amounts in 35 g Active Ingredients Chewable Bar Composition Flavonoidand Colostrum (FlavoCol ™) 500 mg Niacinamide 400 mg L-Theanine(Suntheanine ® brand) 175 mg Chamomile (Matricaria perforata) 200 mgPowder Thiamine (Vitamin B1) 55 mg Pyridoxine (Vitamin B6) 8 mg VitaminB12 15 mcg

The remainder of the weight may comprise inactive ingredients, such as,potato starch, dry whey, glycerine, potato flour, sunflower lecithin,dried yogurt, flaxseed meal, natural chicken flavor, green tea extract,sorbic acid, and phosphoric acid. The pet ingestible bar composition mayinclude at least 15% by weight of crude protein, at least 5% by weightof crude fat, at most 3% by weight of crude fiber, and at most 20% byweight of moisture.

Example VIII: An Exemplary High Protein Composition

In one exemplary embodiment, a pet ingestible bar composition mayprovide a high-protein dietary treat to a dog. For example, the petingestible bar composition may include at least 25% protein. The petingestible bar composition may also include a flavoring agent and ispalatable to a dog. In a particular exemplary embodiment, the pet treatis approximately 35 grams and may include a number of vitamins anddietary supplements in the following amounts:

Amounts in 35 g Active Ingredients Chewable Bar Composition CrudeProtein at least 25% Crude Fat at most 5% Crude Fiber at most 3%Moisture at most 20% Potassium at least 20 mg Chloride at least 15 mgMagnesium at least 3 mg Vitamin E at least 30 IU Thiamine at least 3 mgRiboflavin at least 2 mg Niacin at least 5 mg Pyridoxine at least 2 mgAscorbic Acid at least 50 mg Omega 3 Fatty Acids at least 100 mg Omega 6Fatty Acids at least 50 mg

For example, the pet ingestible bar composition may comprise wheyprotein concentrate, potato starch, glycerin, potato flour, driedyogurt, sunflower lecithin, flaxseed meal, natural chicken flavor,sorbic acid, phosphoric acid, chondroitin sulfate (e.g., porcinesource), isoleucine, leucine, valine, dried beet, Vitamin E Supplement,ascorbic acid, L-carnitine, green tea extract, potassium chloride,magnesium sulfate, salt, niacinamide, riboflavin supplement, thiaminehydrochloride, and pyridoxine hydrochloride.

Example IX: An Exemplary Weight Management Composition

In one exemplary embodiment, a pet ingestible bar composition mayprovide a dietary composition that is formulated to control the weightof or induce weight loss of a dog. The pet ingestible bar compositionmay include a flavoring agent and is palatable to a dog. The petingestible bar may be formulated to provide a sufficient level ofnutrients to the dog, but with a reduced caloric level to help controlthe weight of or help weight loss of the dog. In a particular exemplaryembodiment, the pet ingestible bar composition is approximately 35 gramsand may include active ingredients in the following amounts:

Amounts in 35 g Active Ingredients Chewable Bar Composition PhaseoulusVulgaris 500 mg L-Glutamine 100 mg L-Carnitine 20 mg L-Lysine 20 mgL-Taurine 2 mg Maganese 1.5 mg Thiamine 0.5 mg Potassium 0.002 mg Omega3 fatty acids at least 75 mg Omega 6 fatty acids at least 25 mg

The active ingredients may further include biotin in an amount suitablefor consumption by a pet (e.g., dog, cat or horse). The remainder of theweight may comprise inactive ingredients, such as, potato starch, driedwhey, glycerine, potato flour, sunflower lecithin, dried yogurt,flaxseed meal, natural chicken flavor, sorbic acid, and phosphoric Acid.The pet ingestible bar composition may include at least 15% by weight ofcrude protein, at least 5% by weight of crude fat, at most 3% by weightof crude fiber, and at most 20% by weight of moisture.

The invention described and claimed herein is not to be limited in scopeby the specific embodiments herein disclosed since these embodiments areintended as illustrations of several aspects of this invention. Anyequivalent embodiments are intended to be within the scope of thisinvention. Indeed, various modifications of the invention in addition tothose shown and described herein will become apparent to those skilledin the art from the foregoing description. Such modifications are alsointended to fall within the scope of the appended claims. Allpublications cited herein are incorporated by reference in theirentirety.

What is claimed is:
 1. A chewable composition formulated for oraldelivery to a dog or a cat comprising: a chewable delivery matrixcomprising a yogurt powder, the yogurt powder being at least 3% byweight of the chewable composition, a flavoring agent palatable to thedog or the cat, and water; and at least about 0.01% by weight of aplurality of water-soluble film pieces dispersed homogeneouslythroughout the chewable delivery matrix, the plurality of water-solublefilm pieces comprise an active agent and a coloring agent therein, theactive agent being rapidly releasable from the chewable composition uponcontact with saliva from the dog or the cat, wherein the water in thechewable delivery matrix is in an amount selected for mixing with theplurality of water-soluble film pieces without causing aggregation ofthe water-soluble film pieces.
 2. The composition of claim 1, whereinthe amount of water in the chewable delivery matrix is less than 15% byweight of the chewable composition.
 3. The composition of claim 1,wherein the water-soluble film pieces comprise a film-formingpolysaccharide.
 4. The composition of claim 3, wherein the film-formingpolysaccharide is a natural starch.
 5. The composition of claim 1,wherein the active agent comprises at least one selected from the groupconsisting of vitamins, minerals, nutritional supplements, herbalremedies, and pharmaceutical agents.
 6. The composition of claim 5,wherein the active agent comprise at least one selected from the groupconsisting of anti-plaque agents, anti-inflammatory agents, anti-tumoragents, anesthetics, breath freshening agents, anti-anxiety agents,energizing agents, weight loss agents, vitamins, minerals, and probioticcompositions.
 7. The composition of claim 1, wherein the chewabledelivery matrix further comprises the same active agent as the filmpieces or an additional active agent.
 8. The composition of claim 7,wherein the additional active agent comprises at least one selected fromthe group consisting of vitamins, minerals, nutritional supplements,herbal remedies, and pharmaceutical agents.
 9. The composition of claim1, wherein the chewable delivery matrix further comprises an abrasiveagent for mechanically scrubbing against the teeth of the pet.
 10. Thecomposition of claim 9, wherein the active agent comprises sodiumhexametaphosphate.
 11. The composition of claim 3, wherein thewater-soluble film pieces further comprises at least one of a naturalgum, a humectant, and an emulsifier.
 12. The composition of claim 1,wherein the water-soluble film pieces are uniformly sized and shaped.13. The composition of claim 12, wherein the water-soluble film piecesare rectangular
 14. The composition of claim 13, wherein a ratio of awidth to a length of the rectangular shape is about 1:1 to about 1:10.15. The composition of claim 1, wherein the water-soluble film pieceshave a thickness such that the coloring agent does not leech from thewater-soluble film pieces into the chewable delivery matrix.
 16. Thecomposition of claim 1, wherein the water-soluble film pieces aresubstantially free of dietary fiber.
 17. The composition of claim 1,wherein the water-soluble film pieces comprise from about 5% to about50% by weight of the active agent.
 18. The composition of claim 1,wherein the chewable delivery matrix is substantially free of meatbyproducts, gluten or grain.
 19. The composition of claim 1, wherein thechewable delivery matrix further comprises rosemary or rosemary extract.20. A method for oral delivery of an active agent to a dog or a cat,comprising: orally administering to the dog or the cat a chewablecomposition comprising a delivery matrix and a plurality ofwater-soluble film pieces dispersed homogenously throughout the matrix,the plurality of water-soluble film pieces include the active agenttherein, rapidly dissolving a first portion of the plurality ofwater-soluble film pieces in a mouth of the dog of the cat upon contactwith saliva from the dog or the cat for oromucosal delivery of theactive agent to the dog or the cat, and subsequently releasing theactive agent from a second portion of the plurality of water-solublefilm pieces for delivery to a gastrointestinal track of the dog or thecat.
 21. A composition formulated for oral delivery to a dog or a catcomprising: a delivery matrix comprising at least 15% by weight of crudeprotein, a flavoring agent palatable to the dog or the cat, and water;and at least about 0.01% by weight of a plurality of water-soluble filmpieces dispersed homogeneously throughout the delivery matrix, theplurality of water-soluble film pieces comprise an active agent and acoloring agent therein, the active agent being rapidly releasable fromthe composition upon contact with saliva from the dog or the cat,wherein the water in the delivery matrix is in an amount selected formixing with the plurality of water-soluble film pieces without causingaggregation of the water-soluble film pieces.